King, NC, United States
King, NC, United States

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Coggins C.R.E.,Carson Watts Consulting | Merski J.A.,Altria Client Services Inc. | Oldham M.J.,Altria Client Services Inc.
Inhalation Toxicology | Year: 2011

Context: Three heterocyclic nitrogen compounds, 2,3-diethylpyrazine (DEP), 2,3,5,6-tetramethylpyrazine (TMP), and 2-acetyl pyridine (AP), are naturally present in tobacco and are also added to tobacco as flavor ingredients. Objective: A battery of tests was used to compare the toxicity of mainstream smoke from experimental cigarettes containing the three heterocyclic nitrogen compounds added individually at three different levels. The lowest target inclusion level of the ingredient was 10 ppm, and the highest was 10,000 ppm. Material and methods: Smoke from experimental and control cigarettes was evaluated in analytical smoke chemistry, in vitro cytotoxicity, and mutagenicity assays. Results: The cigarettes with added DEP produced some minor (approximately 10%) changes in smoke chemistry when compared with the cigarettes containing no DEP. Smoke chemistry was effectively unchanged by the addition of either AP or TMP. Cytotoxicity, assessed by the neutral red uptake assay using both gas-vapor and particulate phases of smoke, was unaffected by the addition of any of the test ingredients. Mutagenicity, assessed in five strains of Salmonella treated with mainstream cigarette smoke condensate, also was unaffected by any of the test ingredients. Conclusions: Despite the exaggerated ingredient levels relative to commercial-use levels, there was a lack of a toxicological response for the three heterocyclic nitrogen compounds in the test systems used. © 2011 Informa Healthcare USA, Inc.


Coggins C.R.E.,Carson Watts Consulting | Jerome A.M.,Altria Client Services Inc. | Edmiston J.S.,Altria Client Services Inc. | Oldham M.J.,Altria Client Services Inc.
Inhalation Toxicology | Year: 2011

Context: Aliphatic carbonyl compounds are used as ingredients in cigarette tobacco or cigarette filters. Objective: A battery of tests was used to compare toxicity of mainstream smoke from experimental cigarettes containing 15 aliphatic carbonyl compounds that were added individually to experimental cigarettes at three different levels. Materials and methods: Smoke from experimental and control cigarettes were evaluated using analytical chemistry, in vitro cytotoxicity (neutral red uptake), and mutagenicity (five bacterial strains) studies. For one compound, glycerol triacetate (GTA), two 90-day inhalation studies were also performed, using different inclusion levels into either tobacco or cigarette filter. Results: Several smoke constituent concentrations were reduced with the highest inclusion level of GTA in tobacco; incorporation of GTA into the filter, and the other compounds into tobacco, produced effectively no changes. Cytotoxicity was reduced by the highest inclusion of GTA into tobacco for both gas-vapor and particulate phases of smoke; incorporation of GTA into the filter, and the other compounds into tobacco, showed no changes. Mutagenicity was reduced by the middle and high inclusion levels of GTA into tobacco (TA1537 strain with S9); incorporation of GTA into the filter, and the other compounds into tobacco, showed no changes. Conclusion: Inclusion of GTA in tobacco at 100,000 ppm reduced the biological effects of the smoke in the various test systems reported in this study, although inclusion into the filter did not appear to have any major effect on the endpoints studied. The other 14 aliphatic carbonyl compounds that were tested lacked a toxicological response. © 2011 Informa Healthcare USA, Inc.


Coggins C.R.E.,Carson Watts Consulting | McKinney Jr. W.J.,Altria Client Services Inc. | Oldham M.J.,Altria Client Services Inc.
Inhalation Toxicology | Year: 2013

Context: Historical work indicates that cigarette circumference may affect the toxicological profile of experimental cigarettes. Objective: Studies were conducted to examine the effect of different cigarette circumferences on (1) selected mainstream smoke constituents including concentrations of tobacco specific nitrosamines (TSNA) in smoke and (2) mutagenicity and cytotoxicity of cigarette smoke condensate. Materials and methods: Analytical chemistry, Salmonella mutagenicity and cytotoxicity assays were used to evaluate the composition and biological activity of mainstream smoke from experimental, non-filtered cigarettes manufactured with four different circumferences (17.0-27.1mm). Results: Most smoke constituents, including TSNA, decreased with decreasing cigarette circumference; however, amounts of hydrogen cyanide increased in a non-circumference dependent manner. Mutagenicity and cytotoxicity also decreased slightly with decreasing cigarette circumference. Conclusion: Cigarette circumference may have a minor role in the toxicological profile of experimental cigarettes, with a so-far-unidentified mechanism. © 2013 Informa Healthcare USA, Inc.


Theophilus E.H.,R.J. Reynolds Tobacco Co. | Coggins C.R.E.,Carson Watts Consulting | Chen P.,R.J. Reynolds Tobacco Co. | Schmidt E.,R.J. Reynolds Tobacco Co. | Borgerding M.F.,R.J. Reynolds Tobacco Co.
Regulatory Toxicology and Pharmacology | Year: 2015

Tobacco toxicant-related exposure reduction is an important tool in harm reduction. Cigarette per day reduction (CPDR) occurs as smokers migrate from smoking cigarettes to using alternative tobacco/nicotine products, or quit smoking. Few reports characterize the dose-response relationships between CPDR and effects on exposure biomarkers, especially at the low end of CPD exposure (e.g., 5 CPD). We present data on CPDR by characterizing magnitudes of biomarker reductions. We present data from a well-controlled, one-week clinical confinement study in healthy smokers who were switched from smoking 19-25 CPD to smoking 20, 10, 5 or 0 CPD. Biomarkers were measured in blood, plasma, urine, and breath, and included smoke-related toxicants, urine mutagenicity, smoked cigarette filter analyses (mouth level exposure), and vital signs. Many of the biomarkers (e.g., plasma nicotine) showed strong CPDR dose-response reductions, while others (e.g., plasma thiocyanate) showed weaker dose-response reductions. Factors that lead to lower biomarker reductions include non-CPD related contributors to the measured response (e.g., other exposure sources from environment, life style, occupation; inter-individual variability). This study confirms CPDR dose-responsive biomarkers and suggests that a one-week design is appropriate for characterizing exposure reductions when smokers switch from cigarettes to new tobacco products. © 2015 The Authors.


Gaworski C.L.,Altria Client Services Inc. | Oldham M.J.,Altria Client Services Inc. | Wagner K.A.,Altria Client Services Inc. | Coggins C.R.E.,Carson Watts Consulting | Patskan G.J.,Altria Client Services Inc.
Inhalation Toxicology | Year: 2011

Context: Ingredients have been used in modern cigarette manufacturing to facilitate tobacco processing, provide flavor, and preserve tobacco. Concern has been raised regarding the use of ingredients in cigarette manufacturing due to the possible generation of toxic chemicals resulting from their combustion when added to tobacco. Objective: Investigate the impact of individual ingredients on cigarette smoke toxicity. Materials and methods: A total of 95 ingredients were tested individually through addition at different concentrations to the tobacco of experimental cigarettes. Mainstream cigarette smoke chemistry analysis, bacterial mutagenicity testing, and cytotoxicity testing were conducted. Additionally, 31 of the ingredients were tested in 90-day nose-only rat inhalation studies using mainstream cigarette smoke. Studies were designed following conventional toxicity testing methods employed for food additives and other consumer products. Results: The studies reported here demonstrate that high levels of some ingredients can change the quantity of some smoke constituents, altering the smoke chemistry profile. From the panel of biological endpoints monitored, these added ingredients produced minimal changes in the overall toxicity profile of mainstream cigarette smoke. In some cases, the addition of high levels of an ingredient caused a small reduction in toxicity findings, probably due to displacement of burning tobacco. Conclusion: The battery of testing results presented here is a useful addition to the available scientific information for cigarette ingredients and extends the dataset which can be used for evaluating their appropriate use. © 2011 Informa Healthcare USA, Inc.


Coggins C.R.E.,Carson Watts Consulting | Sena E.J.,Altria Client Services Inc. | Langston T.B.,Altria Client Services Inc. | Oldham M.J.,Altria Client Services Inc.
Inhalation Toxicology | Year: 2011

Context: Aromatic carbonyls are typically used in the processing or flavoring of tobacco used in the manufacture of cigarettes. Objective: A battery of tests was used to compare the toxicity of mainstream smoke from experimental cigarettes containing different added levels of aromatic carbonyl compounds. Materials and methods: Ten aromatic carbonyl compounds, nine of which have been reported in tobacco or in tobacco smoke, were added individually to experimental cigarettes at three different levels. The tenth compound, not found naturally in tobacco, was 2-phenoxyethyl isobutyrate. The lowest target inclusion level was 100 ppm and the highest was 10,000 ppm. Smoke from each of the 10 experimental cigarette types was evaluated using analytical chemistry, in vitro cytotoxicity, and mutagenicity testing. For one of the compounds, ethyl vanillin, a 90-day smoke inhalation study using rats was also performed. Results: Smoke chemistry was effectively unchanged by the addition of any of the compounds. Cytotoxicity, assessed by the neutral red uptake assay and using both gas-vapor and particulate phases of smoke, was unaffected by the addition of any of the test compounds. Mutagenicity, assessed by five strains of Salmonella typhimurium treated with smoke condensate, also was unaffected by any of the test compounds. In the rat inhalation study, there were effectively no differences between cigarettes without added ethyl vanillin and cigarettes containing ~8000 ppm of ethyl vanillin. Conclusion: Even at the exaggerated inclusion levels in cigarette tobacco used in these tests, no adverse toxicological responses occurred for any of aromatic carbonyl compounds tested. © 2011 Informa Healthcare USA, Inc.


Coggins C.R.E.,Carson Watts Consulting | Wagner K.A.,Altria Client Services Inc. | Werley M.S.,Altria Client Services Inc. | Oldham M.J.,Altria Client Services Inc.
Inhalation Toxicology | Year: 2011

Context: Eleven carbohydrates and natural product ingredients were added individually to experimental cigarettes. Objective: A battery of tests was used to compare toxicity of mainstream smoke from these experimental cigarettes to matched control cigarettes without test ingredients. Materials and Methods: Smoke fractions from each cigarette type were evaluated using analytical chemistry; in vitro cytotoxicity (neutral red uptake) and in vitro bacterial (Salmonella) mutagenicity (five strains) testing. For 10 ingredients (β?-cyclodextrin, cleargum, D-sorbitol, high fructose corn syrup, honey, invert sugar, maltodextrin, molasses, raisin juice concentrate, and sucrose), 90-day nose-only smoke inhalation studies using rats were also performed. Results: In general, addition of each ingredient in experimental cigarettes resulted in minimal changes in smoke chemistry; the exceptions were D-sorbitol and sucrose, where reductions in amount of 60% to 80% of control values for some smoke constituents were noted. Additionally, each ingredient resulted in small increases in smoke formaldehyde concentrations. Except for a reduction in cytotoxicity by inclusion of maltodextrin and an increase by inclusion of plum juice concentrate, the cytotoxicity and mutagenicity results were unaffected by addition of the other ingredients in experimental cigarettes. There were also very few statistically significant differences within any of the 10 inhalation studies, and when present, the differences were largely sporadic and inconsistent between sexes. Conclusion: The carbohydrates and natural products tested here as ingredients in experimental cigarettes as a class increased formaldehyde, but resulted in minimal toxicological responses, even at high inclusion levels compared with the levels used in commercial cigarette products. © 2011 Informa Healthcare USA, Inc.


Coggins C.R.E.,Carson Watts Consulting | Sena E.J.,Altria Client Services Inc. | Oldham M.J.,Altria Client Services Inc.
Inhalation Toxicology | Year: 2011

Context: Two ammonia compounds, diammonium phosphate and ammonium hydroxide, are typically used in the processing or flavoring of tobacco used in the manufacture of cigarettes. Objective: A battery of tests was used to compare the toxicity of mainstream smoke from experimental cigarettes containing different added levels of diammonium phosphate (target maximal inclusion level, 50,000 ppm) or both ammonium hydroxide (target maximal inclusion level 11,160 ppm) and diammonium phosphate. Materials and methods: The tests included analytical chemistry, with over 40 constituents in mainstream cigarette smoke; in vitro bacterial (Salmonella) mutagenicity and cytotoxicity (neutral red uptake) assays, and 90-day smoke inhalation studies using rats. Diammonium phosphate acted as a burn retardant, and consequently, the highest planned inclusion level could not be used. Ammonium hydroxide could not be added to cigarettes at meaningfully different levels. Results: Apart from a substantial reduction in smoke concentrations of formaldehyde seen in the smoke chemistry analysis and animal exposure characterization, there were very few endpoints in any of the analyses that showed significant differences as a result of the addition of either of the two ammonia compounds. These differences, when present, occurred only sporadically, with no evidence of any dose-response relationships. Conclusion: The results of these experiments show that the ammonia compounds, diammonium phosphate and ammonium hydroxide, when added to cigarette tobacco, even at high inclusion levels, have minimal toxicological sequelae. © 2011 Informa Healthcare USA, Inc.


Coggins C.R.E.,Carson Watts Consulting | Fisher M.T.,Altria Client Services Inc. | Smith D.C.,Altria Client Services Inc. | Oldham M.J.,Altria Client Services Inc.
Inhalation Toxicology | Year: 2011

Context: Cocoa-derived ingredients are used in cigarette tobacco. Objective: A battery of tests was used to compare toxicity of mainstream smoke from experimental cigarettes containing different added levels of cocoa-derived ingredients. Materials and Methods: Five cocoa-derived ingredients chocolate (CH), cocoa (COC), cocoa-grand prix black (CGPB), cocoa nibs tincture (CNT) and cocoa shells extract (CSE) were added individually to experimental cigarettes at three different levels. Smoke from each of the experimental cigarette types was evaluated using analytical chemistry; in vitro cytotoxicity and mutagenicity testing were performed for four of the five compounds. For CH, COC and CNT, 90-day smoke inhalation studies were performed with 6-week recovery periods. Results: No consistent changes were found in the analytical chemistry results. Results of the cytotoxicity and mutagenicity were unaffected by any of the ingredients. Two of the three inhalation studies showed very few differences between the groups. The inhalation study with COC showed several increases in mean histopathology severity scores in groups exposed to different levels of COC, compared with the controls. These apparent effects of COC on histopathology lesion severity scores were only present in a single sex and none were dose-related, which is not consistent with a true increase in biological activity. Also there were effectively no differences in the patterns of recovery for any of the compounds. Conclusions: Even at high inclusion levels there was a lack of toxicological response in these COC derived ingredients. © 2011 Informa Healthcare USA, Inc.


Coggins C.R.E.,Carson Watts Consulting | Frost-Pineda K.,Altria Client Services Inc. | Smith D.C.,Altria Client Services Inc. | Oldham M.J.,Altria Client Services Inc.
Inhalation Toxicology | Year: 2011

Context: Various aromatic and aliphatic alcohol compounds are found in tobacco and tobacco smoke. Objective: A battery of tests was used to compare the toxicity of mainstream smoke from experimental cigarettes containing eight aromatic and aliphatic alcohol compounds that were added individually to experimental cigarettes at three different levels. The lowest target inclusion level was 100 ppm and the highest level was 24,400 ppm. Materials and methods: Mainstream smoke from each of the cigarette types was evaluated using analytical chemistry and assays to measure in vitro cytotoxicity (neutral red uptake) and Salmonella (five strains) mutagenicity. For three of the compounds (benzyl alcohol, propyl paraben, and rum flavor), 90-day smoke inhalation studies with 6-week recovery periods were also performed using rats. Results: Inclusion of eugenol produced several dose-related reductions in concentrations of selected smoke constituents. Cytotoxicity and mutagenicity were unaffected by any of the test ingredients, except for dose-related reductions in cytotoxicity of the gas vapor phase produced by the inclusion of eugenol. The three smoke inhalation studies showed a few sporadic differences between the groups and there were no differences in the patterns of recovery for any of the ingredients. Conclusions: Despite using exaggerated inclusion levels of the eight aliphatic and aromatic alcohol compounds in experimental cigarettes, there was minimal toxicological response, which is consistent with published reports of studies using mixtures of compounds added to tobacco. © 2011 Informa Healthcare USA, Inc.

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